N/A
Completed N=43
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
Ovarian Cancer · Peritoneal Primary Cancer · Fallopian tube cancer
Source: ClinicalTrials.gov NCT00293293 ↗
Enrolled (actual)
43
Serious AEs
7.0%
Results posted
Jun 2012
Primary outcomePrimary: Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) — 143; 152; 154; 152 Scores on a Scale
Summary
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM) |
143; 152; 154; 152; 158; 152 | — |
| PRIMARY Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM |
195; 191; 182; 189; 196; 197 | — |
| SECONDARY Number of Patients With Delays In Receiving Chemotherapy Alone |
8 | — |
| SECONDARY Number of Patients With Delays In Receiving Chemotherapy Plus CAM |
7 | — |
| SECONDARY Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone |
4.75 | — |
| SECONDARY Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM |
5.95 | — |
| SECONDARY Average Anti-Emetic Dose Use After Chemotherapy Alone |
453.2 | — |
| SECONDARY Average Anti-Emetic Dose Use After Chemotherapy Plus CAM |
604.2 | — |
| SECONDARY Average Natural Killer Cell Count Levels Before Chemotherapy Alone |
213 | — |
| SECONDARY Average Natural Killer Cell Count Levels Before Chemotherapy and CAM |
244 | — |
| SECONDARY Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM |
2; 3 | — |
| SECONDARY Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM |
5; 6 | — |
| SECONDARY Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM |
5653; 6144 | — |
| SECONDARY Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM |
680; 811; 281; 364 | — |
| SECONDARY Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM |
14.07; 8.66 | — |
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
- Patients must have signed an informed consent
Exclusion Criteria
- Previous cancer other than skin cancer
- Previous chemotherapy experience
- Active substance abuse
- Schizophrenia
- Pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00293293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.